Objective: To assess the clinical effect and safety of Shenqi Fuzheng Injection (SQFZI) combined with chemotherapy in treating malignant tumor of digestive tract.
Methods: One hundred and eighty-two patients were randomly divided into 3 groups, the combined therapy group (Group A), the SQFZI group (Group B) and the chemotherapy group (Group C). The remission and stabilization effect on cancer were observed.
Results: The remission rate and stabilizing rate of Group A were 20.2% and 87.9%, and those of the Group C were 15.6% and 68.9%, the difference between the two groups was significant, P < 0.05. The symptom and living quality improving rate of Group A were 78.8% and 42.4% separately, those of the Group B were 73.7% and 68.4% and of the Group C 37.8% and 26.7% respectively, the inter-group differences were significant, P < 0.05. The weight gain rate and effective rate of Group A were 45.5% and 90.9%, of Group C were 13.3% and 40.0%, P < 0.05. SQFZI showed good protective effect on hematopoietic system, 7.7% patients in Group A with WBC count lower than 4 x 10(9)/L after treatment, while in Group C, the percentage reached 22.2%. Moreover, SQFZI could raise activity of NK cell, macrophage and T-lymphcyte subgroups, without any injury on heart, liver and kidney function or other adverse reaction.
Conclusion: SQFZI combined with chemotherapy has certain effect of remitting and stablizing on digestive tract tumor, the clinical effect is significant to patients with Qi-Deficiency, and is safe and reliable.